MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems Retraction Problem (1536); Failure of Device to Self-Test (2937)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.The getinge fse that encounter the issue, troubleshot the iabp unit and found the problem to be the scroll compressor.The fse removed the compressor and replaced with new one (0119-00-0236), and also replaced the power cord (0012-00-1688-01) with reel (0997-00-0596).The fse then reassembled the iabp unit and performed all functional and safety checks to meet factory specifications.Unit passed all calibrations, functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.(b)(6).

Event Description

It was reported that during a functional checkout of the cardiosave intra-aortic balloon pump (iabp) performed by a getinge field service engineer (fse), the iabp had a power-up test fails # 14 (prior compressor failure etf), and the power cord reel would not retract.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that during a functional checkout of the cardiosave intra-aortic balloon pump (iabp) performed by a getinge field service engineer (fse), the iabp had a power-up test fails # 14, and the power cord reel would not retract.There was no patient involvement, and no adverse event reported.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 8363556
• MDR Text Key: 138819362
• Report Number: 2249723-2019-00295
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1